Acyclovir Sodium

ANDA 74758, held by Hospira. Acyclovir Sodium.

As of Nov 14, 2026, ANDA 74758 (Acyclovir Sodium), held by Hospira, was first approved by FDA on Apr 22, 1997, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1997
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Apr 22, 1997	Original application	Approved	None posted

Products

2 strengths and forms


Acyclovir SodiumEQ 500MG BASE/VIAL · injectable;injection	Acyclovir Sodium	Discontinued
Acyclovir SodiumEQ 1GM BASE/VIAL · injectable;injection	Acyclovir Sodium	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Mar 19, 2003	Supplement 5Labeling	Approved	None posted
Jul 24, 2000	Supplement 4Labeling	Approved	None posted
Oct 6, 1999	Supplement 1Manufacturing	Approved	None posted
Oct 6, 1999	Supplement 2Manufacturing	Approved	None posted
Oct 6, 1999	Supplement 3Labeling	Approved	None posted
Apr 22, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74758
Drugs@FDA: Overview at FDA
Company: Hospira

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters